9600-07 Nano Form

Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials (Renewal)

2517.04 Attachment B_Nano Form 9600-07

Form Completion, CBI Substantiation, Form Submission, Recordkeeping, and Rule Familiarization (Manufacturers & Processors)

OMB: 2070-0194

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U.S. ENVIRONMENTAL PROTECTION AGENCY

AGENCY USE ONLY:

Document control number

OMB Control No. 2070-0194:
Expiration Date: 09/30/2024

EPA case number

Date of receipt

TSCA §8(a) REPORTING FOR CHEMICAL SUBSTANCES
WHEN MANUFACTURED OR PROCESSED AS
NANOSCALE MATERIALS: DATA SUBMISSION FORM

GENERAL INSTRUCTIONS
• This form is to be used for reporting as prescribed in 40 CFR 704.20. As indicated in that regulation, definitions in TSCA and
40 CFR part 704 apply.
• You must provide information requested in this form to the extent it is known to or reasonably ascertainable by you. “Known
to or reasonably ascertainable by” is defined in 40 CFR §704.3. Make reasonable estimates if you do not have actual data.
• You must provide the currently correct Chemical Abstracts (CA) name of the chemical substance and material characterization
data described in Part I, section C4 when it is known or reasonably ascertainable.
• As much of this form is adapted from the Premanufacture Notice (PMN) form (EPA Form No. 7710-25), it may be instructive
to read “Instruction Manual for Reporting Under the TSCA §5 New Chemicals Program” (available from the Toxic
Substances Control Act (TSCA) Information Service, 202-554-1404, or 202-554-5603(fax) or at
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/instruction-manual-reporting-under.
• If there are several manufacture, processing, or use operations to be described in Part II, sections A and B of this form,
reproduce the sections as needed.
• Attach additional sheets if there is not enough space to answer a question fully. Label each continuation sheet with the
corresponding section heading. In Part III of this Form, list all attachments, including any continuation sheets, any test data
reports or other data and any optional information provided.
• Only one chemical substance may be submitted per form unless you have consulted with EPA to submit a consolidated notice.
• Any information may be claimed as confidential. To assert a claim on the form, mark (X) the confidential box next to the
information claimed as confidential. To assert a claim in an attachment, circle or bracket the information claimed as
confidential. If information is claimed as confidential, a sanitized version (including attachments) must be provided with your
submission and should be labeled as such.
• You are required to submit all existing data concerning the environmental and health effects of the substance known to or
reasonably ascertainable by you. Standard literature citations may be submitted for data in the open scientific literature.
Submit a complete test data report (written in English, if available), not summary data, unless the test data report appears in
the open literature. Clearly identify whether test data is on the chemical substance, on an analog, or from models.
Characterize the chemical composition of the tested material.
• You may want to consult with your customers or suppliers about the confidentiality of any information you report about them
on this form.
TEST DATA
Data must be submitted according to the requirements of 40 CFR §704.20. In addition, hazard and exposure test data are most
useful if the physical/chemical properties of the nanoscale material relevant to assessing test results are obtained at the initiation
of testing. Additional relevant information on preparation of the nanoscale material for administration and storage history of the
material between production and administration is not required but can assist in interpretation. Indicate which of the following
data are included in this submission:
Physical / Chemical properties

Health effects

Environmental effects

Structure / activity relationships

Exposure

Environmental fate

Mark (x) if any information in your submission package is claimed as confidential.

EPA FORM 9600-07

Page 1 of 18

PAPERWORK REDUCTION ACT NOTICE

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501
et seq. (OMB Control No. 2070-0194). Responses to this collection of information mandatory (40 CFR 704).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for
this collection of information is estimated to be 121 hours per response. Send comments on the Agency’s need
for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing
respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency
(2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any
correspondence. Do not send the completed form to this address.
I authorize sharing of all confidential business information with Environment and Climate Change Canada and Health Canada.
Any shared confidential information would be subject to the confidential business information protection laws and policies of
those agencies.
CHECK LIST
Please verify that the questions in the following general areas were answered by marking (X) in the boxes. (Answers may include,
for example, “N/A,” “none,” “not known”).
Physical and chemical characterization
Risk management information
CERTIFICATION
I certify that to the best of my knowledge and belief that all information entered on this form is complete and accurate.
1.

The company named in Part I, section A, subsection 1a of this form manufactures, imports, or processes or intends to
manufacture, import, or process for a commercial purpose (as those terms are defined in TSCA and 40 CFR Part 704), the
chemical substance identified in Part I section B.

2.

I am submitting with this form all existing data concerning the environmental and health effects and all other required data
known to or reasonably ascertainable by me as required by 40 CFR §704.20.

I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for protection for any confidential information made with this
submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that the person
submitting the claim has:
(i)
taken reasonable measures to protect the confidentiality of the information;
(ii)
determined that the information is not required to be disclosed or otherwise made available to the public under any other
Federal law.
(iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position
of the person; and
(iv) a reasonable basis to conclude that disclosure of the information is not readily discoverable through reverse engineering.
Mark (X) the “Confidential” box on the right if you claim the signature and title as confidential.
Signature and title of Authorized Official (Original Signature Required)

EPA FORM 9600-07

Confidential

Date

Page 2 of 18

Part I -- GENERAL INFORMATION

Section A -- SUBMITTER IDENTIFICATION
Mark (X) the “Confidential” box in the right column next to any subsection you claim as confidential
1a. Person
Name of authorized official
Position
Submitting
(in U.S.)
Company

ConfiDential

Mailing address (number and street)
City, State, ZIP Code
b. Other Person
Submitting (in
U.S.)

Name of authorized official

Position

Company
Mailing address (number and street)
City, State, ZIP Code
c.

Telephone

Area Code

Number

Area Code

Number

Area Code

Number

If you are submitting this as part of a joint submission, mark (X) this box.

Joint Submitter (if
applicable)

Name of authorized official

Position

Company
Mailing address (number and street)

2.

Technical
Contact (in
U.S.)

City, State, ZIP Code

Telephone

Name of authorized official

Position

Company
Mailing address (number and street)
City, State, ZIP Code

EPA FORM 9600-07

Telephone

Page 3 of 18

Part I – GENERAL INFORMATION – Continued

Section B -- CHEMICAL IDENTITY INFORMATION: **
Mark (X) the “Confidential” box next to any item you claim as confidential
Complete either item 1 (Class 1 or 2 substances) or 2 (Polymers) as appropriate. Complete all other items.

1.

If another person will submit chemical identity information for you (for either Item 1 or 2), mark (X) the box at the right.
Identify the name, company, and address of that person in a continuation sheet.
Class 1 or 2 chemical substances (for definitions of class 1 and class 2 substances, see the Instructions Manual)

Confidential

a.
b.

Class of substance - Mark (X)
1
Class 1
or 2
Class 2
Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. **

c.

Identify which method you used to develop or obtain the specified chemical identity information: (check one).

d.

Method 1 (CAS Inventory Expert Service
Molecular formula and CAS Registry Number (if a number already exists for the substance)

Method 2 (Other Source)

CAS#

e.

For a class 1 substance, provide a complete and correct chemical structure diagram. For a class 2 substance - (1) List the immediate
precursor substances with their respective CAS Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the
range of composition and the typical composition (where appropriate). (4) Provide a correct representative or partial chemical structure
diagram, as complete as can be known, if one can be reasonably ascertained. (5) Note: the components of a composite can be separate
chemical identities. For example in a composite of starch molecules between layers of clay treated with surfactants, the starch, clay, and
surfactants might be on the TSCA Inventory, but since the interactions between the components are weak electrical interactions, there is no
single chemical substance representing the composite as a whole.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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Part I -- GENERAL INFORMATION – Continued

Section B -- CHEMICAL IDENTITY INFORMATION – Continued
2. Polymers (For a definition of polymer, see the Instructions Manual.)
a.

Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture.
Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) below 500 and
below 1,000 absolute molecular weight of that composition.
Describe the methods of measurement or the basis for your estimates:

b.

Confidential

i)

lowest number average molecular weight:

ii)

maximum weight % below 500 molecular weight:

iii)

maximum weight % below 1000 molecular weight:

GPC

Other

: (Specify)

Mark (X) this box if you attach a continuation sheet.
Make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the “Confidential”
box next to any item you claim as confidential
(1) Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of
the polymer.
(2) Mark (X) this column if entry in column (1) is confidential.
(3) Indicate the typical weight percent of each monomer or other reactant in the polymer.
(4) Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the polymer
description on the TSCA Chemical Substance Inventory.
(5) Mark (X) this column if entries in columns (3) and (4) are confidential.
(6) Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for
commercial purposes.
(7) Mark (X) this column if entry in column (6) is confidential.
Monomer or other reactant and CAS Registry Number
ConfiTypical
Identity
ConfiMaximum
Confidential
composition
(4)
dential
residual
dential
(1)
(2)
(3)
(5)
(6)
(7)
%
%
%

%

%

%

%

%

%

%

%

%

%

%

Mark (X) this box if you attach a continuation sheet.
c.
Identify which method you used to develop or obtain the specified chemical identity information (check one).
Method 1 (CAS Inventory Expert Service)

Method 2 (other source)

d.

The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers.

e.

Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

Page 5 of 18

Part I -- GENERAL INFORMATION -- Continued

Section B -- CHEMICAL IDENTITY INFORMATION – Continued
3. Impurities
(a) Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide the
CAS Registry Number if available. If there are unidentified impurities, enter “unidentified.”
(b) Estimate the maximum weight % of each impurity. If there are unidentified impurities, estimate their total weight %.
Impurity and CAS Registry Number
Maximum
Confi(a)
percent
dential
(b)
%
%
%
%
%
%
%

Mark (X) this box if you attach a continuation sheet.
4. Synonyms - Enter any chemical synonyms for the chemical identified in subsection 1 or 2.

Confidential

Mark (X) this box if you attach a continuation sheet.
5.

Trade identification - List trade names for the chemical substance identified in subsection 1 or 2.

Mark (X) this box if you attach a continuation sheet.
6. Generic chemical name -

If you claim chemical identify as confidential, provide a generic name for your substance that reveals the
specific chemical identity of the chemical substance to the maximum extent possible. Refer to the TSCA
Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names.

Mark (X) this box if you attach a continuation sheet.
7. Byproducts Describe any byproducts resulting from the manufacture, processing, use, or disposal of the chemical substance. Provide the CAS Registry
Number if available.
Byproduct
CAS Registry Number
Confi(1)
(2)
dential

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

Page 6 of 18

Part I – GENERAL INFORMATION – Continued

Section C -- PRODUCTION, IMPORT, AND USE INFORMATION:
Mark (X) the “Confidential” box next to any item you claim as confidential.

1. Production volume – Report the production volume during calendar year 20XX. Also estimate the maximum production volume for any
consecutive 12-month period during the next three years of production. Make estimates on a 100% chemical substance basis.

Production volume for 20XX (kg/yr)
(100% chemical substance basis)

Maximum 12-month production volume (kg/yr)
(100% chemical substance basis)

Confidential

2. Use Information -- Make separate confidentiality claims for the description of the category of use, the percent of production volume devoted to
each category, the formulation of the substance, and other use information. Mark (X) the “Confidential” box next to any item you claim as
confidential.
a. (1) -- Describe each category of use of the chemical substance by function and application.
(2) -- Mark (X) this column if entry column (1) is claimed as confidential business information (CBI).
(3) -- Estimate the percent of total production volume devoted to each category of use.
(4) -- Mark (X) this column if entry in column (4) is claimed as CBI.
(5) -- Estimate the percent of the substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for
commercial purposes at sites under your control associated with each category of use.
(6) -- Mark (X) this column if entry in column (6) is claimed as CBI.
(7) -- Indicate % of product volume expected for the listed “use” sectors. Mark more than one box if appropriate.
(8) -- Mark (X) this column if entry(ies) in column (8) is (are) claimed as CBI.
Category of use (1)

CBI

CBI

(by function and application i.e. a coating for
automobile body parts)

Production %

(2)

(3)

(4)

%

% in
Formulation
(5)
%

%

%

%

%

%

%

%

%

%

%

%

%

CBI
(6)

Sitelimited

% of substance expected per use
(7)
Con-*
IndusComsumer
trial
mercial

CBI
(8)

* If you have identified a “consumer” use, please provide on a continuation sheet a detailed description of the use(s) of this chemical substance in consumer products.
In addition include estimates of the concentration of the chemical substance as expected in consumer products and describe the chemical reactions by which this
substance loses its identity in the consumer product.
Mark (X) this box if you attach a continuation sheet.
If you claim any category of use description in subsection 2a as confidential, enter a generic description of that category. Read the
b. Generic
Instructions Manual for examples of generic use descriptions.
use description

Mark (X) this box if you attach a continuation sheet.
3. Hazard Information -- Include a copy or reasonable facsimile of any hazard warning statement, label, material safety data sheet, or other information
which is provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe
handing, transport, use, or disposal of the substance. List in part III hazard information you include.
Mark (X) this box if you attach hazard information.

EPA FORM 9600-07

Page 7 of 18

Section C –-Continued

Part I – GENERAL INFORMATION – Continued
Mark (X) the “CBI” box next to any item you claim as confidential.

4. Material characterization – Describe characteristics of the nanoscale material used to distinguish it from other discrete forms
of the nanoscale material, as described in 40 CFR 704.20, including but not limited to the particle size, morphology, encapsulation,
and formulation.

CBI

Mark (X) this box if you attach a continuation sheet.

5. Briefly describe any unique or novel properties that arise from the nanoscale features of the material, particularly in contrast to any nonnanoscale varieties that exist.

Mark (X) this box if you attach a continuation sheet.

6. Briefly explain why this material is designed and/or produced to be a nanoscale material.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

Page 8 of 18

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
Section A – INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER

Mark (X) the CBI box next to any item you claim as
confidential.

Complete section A for each type of manufacture, processing, or use operation involving the chemical substance at industrial sites you control.
See instructions manual
1. Operation description
CBI
a. Identity -- Enter the identity of the site at which the operation occurs.
Name

Site address (number and street)
City, County, State, ZIP code

If the same operation occurs at more than one site, enter the number of sites. Identify the
additional sites on a continuation sheet, and if any of the sites have significantly different
production rates or operations, include all the information requested in this section for those
sites as attachments.
b.
c.

Mark (X) this box if you attach a continuation sheet.

Type -Mark (X)

Manufacturing
Amount and Duration -- Complete 1 or 2 as appropriate
Maximum kg/batch (100%

chemical
substance)

Processing

Use

Hours/batch

Batches/year

Hours/day

Days/year

1. Batch
Maximum kg/day (100%

chemical
substance)

2. Continuous
d. Process description
(1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon
drum, rail car, tank truck, etc.).
(2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% chemical substance basis), and entry point of all starting materials and
feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not
used daily or per batch.).
(3) Identify by number the points of release, including small or intermittent releases, to the environment of the chemical substance. If releasing to two media at
the same step, assign a second release number for the second medium.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

Page 9 of 18

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued

Section A – INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER – Continued

2. Occupational Exposure -- Make separate confidentiality claims for the description of worker activity, physical form of the chemical substance, number of workers
exposed, and duration of activity. Mark (X) in the “CBI” column next to any item you claim as confidential.
(1) -- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the substance.
(2) -- Mark (X) this column if entry in column (1) is claimed CBI.
(3) -- Describe any protective equipment and engineering controls used to protect workers.
(4) -- Indicate the physical form(s) of the chemical substance (e.g., solid: crystal, granule, powder, or dust) and % chemical substance (if part of a mixture) at the
time of exposure.
(5) -- Mark (X) this column if entry in column (4) is claimed CBI.
(6) -- Estimate the maximum number of workers involved in each activity for all sites combined.
(7) -- Mark (X) this column if entry in column (6) is claimed CBI.
(8) and (9) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year.
(10) -- Mark (X) this column if entries in columns (8) and (9) are claimed CBI.
CBI
Physical forms(s)
CBI
CBI
Maximu Duration CBI
Worker activity
Protective Equipment/
# of
(i.e., bag dumping, filling drums)
(1)

Engineering Controls
(2)

and % substance
(4)

(3)

(5)

Workers
Exposed
(6)

(7)

m
Hrs/day

Days/yr

(8)

(9)

(10)

Mark (X) this box if you attach a continuation sheet.
3. Environmental Release and Disposal -- Make separate confidentiality claims for the release number and the amount of the chemical substance released and other
release and disposal information. Mark (X) in the CBI column next to each item you claim as confidential.
(1) -- Enter the number of each release point identified in the process description, part II, section A, subsection 1d(3).
(2) -- Estimate the amount of the substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch).
(3) -- Mark (X) in this column if entries in columns (1) and (2) are claimed as CBI.
(4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to
which the substance is released from that release point.
(5) -- a. Describe control technology, if any, and control efficiency that is used to limit the release of the substance to the environment. For releases disposed of on
land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet, for each site describe
any additional disposal methods that is used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate the amount released to the
environment after control technology (in kg/day).
(6) -- Mark (X) in this column if entries in columns (4) and (5) are claimed as CBI.
(7) -- Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or
NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is claimed as CBI.
CBI
Release Amount of substance released CBI Media of
Control technology and efficiency (you may wish to optionally attach efficiency data)
release
Number
e.g. stack air
(1)
(2a)
(2b)
(4)
(3)
(5a)
(5b)
(6)

(7) Mark (X) the
destination(s) of
releases to water.

POTW provide name(s) below:

CBI

Navigable
waterway

Other - Specify

provide NPDES #

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

Page 10 of 18

CBI

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued

Section B – INDUSTRIAL SITES CONTROLLED BY OTHERS

Complete section B for typical processing or use operations involving the chemical substance at sites you do not control. See the Instructions Manual. Complete a
separate section B for each type of processing, or use operation involving the chemical substance. If the same operation is performed at more than one site describe the
typical operation common to these sites. Identify additional sites on a continuation sheet.

1. Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential.

(1) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e.g. 5 gallon pails, 55 gallon
drums, rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2) -- Provide the identity, the approximate weight
(by kg/day or kg/batch, on a 100% chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all products,
recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- Identify by number the points of release, including
small or intermittent releases, to the environment of the chemical substance. (4) Please enter the # of sites (remember to identify the locations of these sites on a
continuation sheet):

# of sites

Mark (X) this box if you attach a continuation sheet.
2. Worker Exposure/Environmental Release
(1) -- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described.
(2) -- Estimate the number of workers exposed for all sites combined.
(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year.
(6) -- Describe physical form of exposure and % chemical substance (if in mixture), and any protective equipment and engineering controls, if any,
used to protect workers.
(7) -- Estimate the percent of the substance as formulated when packaged or used as a final product.
(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified.
(10) -- Estimate the amount of the substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or
kg/batch).
(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration,
POTW, or other (specify) and control technology that is used to limit the release of the substance to the environment.
(14) -- Identify byproducts which result from the operation.
(3), (5), (8), (11), (13) and (15) -- Mark (X) in these columns if any of the proceeding entries are claimed as CBI.

Letter
of
Activity

# of
Workers
Exposed

CBI

(1)

(2)

(3)

Duration
of
Exposure

(4a)

(4b)

CBI

(5)

Protective Equip. /
Engineering Controls/
Physical Form and %
Substance
(6)

% in
Formulation

CBI

Release
Number

(7)

(8)

(9)

Amount of
Substance
Released

(10a)

(10b)

CBI

Media of Release
& Control
Technology

CBI

(11)

(12)

(13)

(14) -- Byproducts:

(15)

Mark (X) this box if you attach a continuation sheet,

EPA FORM 9600-07

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Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued

Section A / B, Subsection 2. Occupational Exposure – Continued. b. Details of protective equipment / engineering controls.

(Use this form both for sites controlled by submitter and by others. Make copies as necessary.)
Provide the following information:
(1) – The worker activities listed in Section A.2 or B.1 for which protective equipment/engineering controls are in use.
(2) – A brief description of the rationale for selecting the protective equipment/engineering controls, including internal exposure control limits,
data and the methods used to generate the data that informed the decision.
(3) – A brief description of the cleaning, reuse, and/or disposal of the protective equipment
(4) – A brief description of any data (personal and/or area), units (e.g., mass conc., surface area, or particle number conc.) and
Any exposure monitoring methods used.
Mark (X) in the “CBI” column next to any item you claim as confidential. CBI

(1) Worker activity / Protective equipment / Engineering Control

(2) Rationale for selecting equipment / controls, associated internal exposure control limit / data / methods

Mark (X) this box if you attach a continuation sheet.

(3) Cleaning, reuse, and/or disposal of protective equipment

Mark (X) this box if you attach a continuation sheet.

(4) Exposure monitoring data (personal and/ or area), units (e.g., mass conc., surface area, or particle number conc.), and
methods used

Mark (X) this box if you attach a continuation sheet.
Mark (X) this box if you attach a continuation sheet.

Section A.3 / Section B, subsection 2. Environmental Release and Disposal – Continued. Details of control technology.

(Use this form both for sites controlled by submitter and by others. Make copies as necessary)
To assist EPA in gaining a better understanding of the need for and the types of control technology used at the release points in the manufacture and
handling of engineered nanoscale materials, provide the following information for each release point for which control technology is used:
(1) – The Release Number, as identified in the process description, part II, section A, subsection 1d(3) (page 8).
(2) – A brief description of the rationale for selecting the control technology.
(3) – Data and measurement methods of waste treatment efficiency studies.

Release
Number (1)
(2) Rationale for selecting control technology

Mark (X) in the “CBI” column next to any item you claim as confidential.

CBI

Mark (X) this box if you attach a continuation sheet.

(3) Data and measurement methods of waste treatment or purification studies

Mark (X) this box if you attach a continuation sheet.
Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued
Section C – Misc. Health, Exposure, Hazard Information

Mark (X) the “CBI” box next to any item you claim as confidential.
1. Describe any training, hazard communication (e.g. MSDS), etc. specific to the nanoscale material that is provided to workers.

CBI

Mark (X) this box if you attach a continuation sheet.

2. Estimate the total number of individuals—other than previously described workers—(e.g. general public, consumers) who may be
exposed to the material and the duration of the exposure.

Mark (X) this box if you attach a continuation sheet.

3. Describe any other procedure, equipment, etc. being used to mitigate exposure to the material.

Mark (X) this box if you attach a continuation sheet.

4. Describe product labeling and any customer training specific to the nanoscale material.

Mark (X) this box if you attach a continuation sheet.

5. Describe other risk management practices specific to the nanoscale material.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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Page

Part III - OPTIONAL POLLUTION PREVENTION INFORMATION

To claim information in this section as confidential circle or bracket the specific information that you claim as confidential.
In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential
risks associated with activities surrounding manufacturing, processing, use and disposal of the substance. Please include information
pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the
chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological
modification, process and procedure modification, product reformulation, raw materials substitution, and/or inventory control.
Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air
emissions or water discharges, or land disposal. Descriptions of pollution prevention, source reduction and recycling should
emphasize potential risk reduction subsequent to compliance with existing regulatory requirements and can be either quantitative or
qualitative. EPA is interested in the information to assess overall net reductions in toxicity or environmental releases and exposures,
not the shifting of risks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In
addition, information on the relative cost or performance characteristics of the substance to potential alternatives may be provided.

See Pollution Prevention Guidance in Instructions Manual for guidance and examples.

Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in the
volume manufactured; (3) a reduction in the generation of waste materials through recycling, source reduction or other means; (4) a
reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in
the cost of production and/or improved operation efficiency of the chemical substance in comparison to existing chemical substances
used in similar application; or (6) the extent to which the chemical substance may be a substitute for an existing substance that poses a
greater overall risk to human health or the environment.

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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Part IV -- LIST OF ATTACHMENTS
List and then attach continuation sheets for sections of the form; test data and other data (including physical/chemical properties and
structure/activity information), and optional information you are providing. Clearly identify the attachment and the section of the form to
which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page
numbers of each attachment.
Mark (X) in the “Confidential” column next to any attachment name you claim as confidential. Read the Instructions Manual for
guidance on how to claim any information in an attachment as confidential. Include with the sanitized copy of the form a sanitized
version of any attachment in which you claim information as confidential.
Attachment name

Attachment
page number(s)

Confidential

Safety Data Sheet (SDS)

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

To assist EPA’s review of physical and chemical properties data, summarize data you have already provided or used to complete the
reporting form. Identify the property measured, the page of the form on which the property appears, the value of the property, the units
in which the property is measured (as necessary), the physical state of the neat substance, and whether or not the property is claimed as
confidential. If properties are not measured for the neat (100% pure) chemical substance then the measured mixtures or formulations
can be noted (% substance in __). It is noted that, for nanoscale materials, protocols and methods may not exist or be standardized for
measurement of the physical and chemical properties listed in this worksheet.
1.

Mark
Page
(X) if number
provided

Physical state of neat substance
Vapor pressure
@ Temperature

°C

Measured or Confidential
Estimate

Mark (X)

(M or E)

(s)

(l)

(g)
Torr

Density/relative density
Solubility
@ Temperature

Value

g/cm3
°C

Solvent
Solubility in water @ Temperature

g/L
°C

Melting temperature
Boiling / sublimation temperature@

g/L
°C

torr pressure

°C

Spectra
Dissociation constant

Octanol / water partition coefficient
Henry’s Law constant
Volatilization from water
Volatilization from soil
pH@ concentration
Flammability
Explodability
Adsorption / coefficient

EPA FORM 9600-07

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PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET Cont – Nanoscale Materials Specific Data
2. To assist EPA’s review of physical and chemical properties data, summarize data you have already provided or used to
complete the reporting form. Identify the property measured, the page of the form on which the property appears, the value of the
property, the units in which the property is measured (as necessary), the physical state of the neat substance, and whether or not the
property is claimed as confidential. If properties are not measured for the neat (100% pure) chemical substance then the measured
mixtures or formulations can be noted (% substance in __). It is noted that, for nanoscale materials, protocols and methods may not
exist or be standardized for measurement of the physical and chemical properties listed in this worksheet.
Property

General Characteristics
Crystal structure

Mark (X) Page
if
number
provided

Value

Measured / CBI
Estimated Mark
(M or E) (X)

Agglomeration state
Particle Characteristics
Particle size distribution
Mean particle size (diameter and/or length)

Provide graph with percentage of particles in each diameter
class. For elongated particles, provide length distribution
graph showing the percentage of particles in each length class.

nm

Standard deviation from mean
Largest particle size (diameter and/or length)
Smallest particle size (diameter and/or length)

nm
nm

Aspect ratio
Average aerodynamic diameter
Average particle mass

nm
g

Particle shape
Surface Characteristics
Surface area
Average particle surface area
Surface charge (Zeta potential)

m2/g
m2
mV

Porosity
Surface chemical composition
Surface / volume ratio
Other
Other

Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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cal to
PMN

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET Cont– Nanoscale Materials Specific Data
3. To assist EPA’s review of physical and chemical properties data, summarize data you have already provided or used to
complete the reporting form. Identify the property measured, the page of the form on which the property appears, the value of the
property, the units in which the property is measured (as necessary), the physical state of the neat substance, and whether or not the
property is claimed as confidential. If properties are not measured for the neat (100% pure) chemical substance then the measured
mixtures or formulations can be noted (% substance in __). It is noted that, for nanoscale materials, protocols and methods may not
exist or be standardized for measurement of the physical and chemical properties listed in this worksheet.

Fate and Transport
Diffusion rate

Mark (X) Page
if
number
provided

Value

Measured / CBI
Estimated Mark
(M or E) (X)

Gravitational settling rate
Sorption rate
Deposition rate
Wet and dry transport
Biodegradation rate
Bioaccumulation
Biotransformation
Influence of redox/photochemical reaction
Other
Other
Mark (X) this box if you attach a continuation sheet.

EPA FORM 9600-07

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File Typeapplication/pdf
AuthorDon Sadowsky
File Modified2024-01-22
File Created2024-01-22

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